Protection of Human Subjects

The CHTN's operating policies and procedures protect the subjects from whom CHTN specimens are obtained. These policies and procedures are consistent with current regulations and guidance for repositories from the Office of Human Research Protections (OHRP, DHHS), http://www.hhs.gov/ohrp/humansubjects/guidance/.

All divisions of the CHTN operate with the review and approval of their local Institutional Review Board (IRB). The following policies and procedures govern collection of specimens and their distribution to investigators:

CHTN specimens are derived from material that is removed as part of routine medical care or autopsy specimens collected in accordance with operative state and local law. Residual material not needed for patient care is distributed for research.

Every CHTN institution has obtained human subjects assurance from the Office of Human Research Protections, DHHS. The Assurance document provides agreement that the institution will comply with federal human subjects regulations (The "Common Rule;" 45 CFR part 46).

Each Division of the CHTN is approved by its local IRB to collect and distribute biospecimens. The IRBs review the procedures in place to ensure adequate protection of human subjects and protection of patient privacy and confidentiality. The approvals are reviewed by the IRB yearly.

Donor identities or other identifying information is never provided to investigators; thus, tissue is provided as either anonymized, de-identified, or as a limited data set. Specimens are assigned a unique code and every CHTN employee has signed an agreement to protect patient privacy and confidentiality.

Each investigator must document review by his/her IRB of the specific research proposed. It is up to the local IRB to determine whether or not the proposed research requires IRB approval. The investigator and his/her institutional official must also sign the agreement form indicating that they agree not to attempt to obtain information identifying the individuals providing tissue to the CHTN and that they will not share the tissue with third parties. This approach is consistent with current OHRP guidance for tissue repositories.